Recharge Kit w/ POC, Omnibut

GUDID D990RKPOCOA0

Smart Denture Conversions, LLC

Dental implant suprastructure, temporary, preformed, single-use
Primary Device IDD990RKPOCOA0
NIH Device Record Keyf8b60b7f-c6f4-4dc5-8884-9b85e0dfd83a
Commercial Distribution StatusIn Commercial Distribution
Brand NameRecharge Kit w/ POC, Omnibut
Version Model NumberRKPOC-OA
Company DUNS010613514
Company NameSmart Denture Conversions, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8555500707
Emailcontacat@smartdentureconversions.com
Phone8555500707
Emailcontacat@smartdentureconversions.com
Phone8555500707
Emailcontacat@smartdentureconversions.com
Phone8555500707
Emailcontacat@smartdentureconversions.com
Phone8555500707
Emailcontacat@smartdentureconversions.com
Phone8555500707
Emailcontacat@smartdentureconversions.com
Phone8555500707
Emailcontacat@smartdentureconversions.com
Phone8555500707
Emailcontacat@smartdentureconversions.com
Phone8555500707
Emailcontacat@smartdentureconversions.com
Phone8555500707
Emailcontacat@smartdentureconversions.com
Phone8555500707
Emailcontacat@smartdentureconversions.com
Phone8555500707
Emailcontacat@smartdentureconversions.com
Phone8555500707
Emailcontacat@smartdentureconversions.com
Phone8555500707
Emailcontacat@smartdentureconversions.com
Phone8555500707
Emailcontacat@smartdentureconversions.com
Phone8555500707
Emailcontacat@smartdentureconversions.com
Phone8555500707
Emailcontacat@smartdentureconversions.com
Phone8555500707
Emailcontacat@smartdentureconversions.com
Phone8555500707
Emailcontacat@smartdentureconversions.com
Phone8555500707
Emailcontacat@smartdentureconversions.com
Phone8555500707
Emailcontacat@smartdentureconversions.com
Phone8555500707
Emailcontacat@smartdentureconversions.com
Phone8555500707
Emailcontacat@smartdentureconversions.com
Phone8555500707
Emailcontacat@smartdentureconversions.com
Phone8555500707
Emailcontacat@smartdentureconversions.com
Phone8555500707
Emailcontacat@smartdentureconversions.com
Phone8555500707
Emailcontacat@smartdentureconversions.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD990RKPOCOA0 [Primary]

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D990RKPOCOA0]

Moist Heat or Steam Sterilization


[D990RKPOCOA0]

Moist Heat or Steam Sterilization


[D990RKPOCOA0]

Moist Heat or Steam Sterilization


[D990RKPOCOA0]

Moist Heat or Steam Sterilization


[D990RKPOCOA0]

Moist Heat or Steam Sterilization


[D990RKPOCOA0]

Moist Heat or Steam Sterilization


[D990RKPOCOA0]

Moist Heat or Steam Sterilization


[D990RKPOCOA0]

Moist Heat or Steam Sterilization


[D990RKPOCOA0]

Moist Heat or Steam Sterilization


[D990RKPOCOA0]

Moist Heat or Steam Sterilization


[D990RKPOCOA0]

Moist Heat or Steam Sterilization


[D990RKPOCOA0]

Moist Heat or Steam Sterilization


[D990RKPOCOA0]

Moist Heat or Steam Sterilization


[D990RKPOCOA0]

Moist Heat or Steam Sterilization


[D990RKPOCOA0]

Moist Heat or Steam Sterilization


[D990RKPOCOA0]

Moist Heat or Steam Sterilization


[D990RKPOCOA0]

Moist Heat or Steam Sterilization


[D990RKPOCOA0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-27
Device Publish Date2025-05-19

Devices Manufactured by Smart Denture Conversions, LLC

D99023BLXOA0 - Omnibut, Straumann BLX2025-05-27
D99023NANPOA0 - Omnibut, Nobel NP2025-05-27
D99023NARPOA0 - Omnibut, Nobel RP2025-05-27
D99023NEOGMOA0 - Omnibut, Neodent GM2025-05-27
D99023ZIH35OA0 - Omnibut, Zimmer Internal Hex 3.52025-05-27
D99023ZIH45OA0 - Omnibut, Zimmer Internal Hex 4.52025-05-27
D99023ZIH57OA0 - Omnibut, Zimmer Internal Hex 5.72025-05-27
D990CC1PK0 - Comfort Cap 1PK2025-05-27

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